2018 -2021 Senior Director, Neurosciences, Global Regulatory Affairs @
2017 -2018 Global Regulatory Lead @
2017 -2017 Head of Regulatory Affairs US and Canada (interim) @
2016 -2017 Lead, Regulatory Affairs - New Product Development, GE Healthcare Life Sciences @
2014 -2015 Boston Site Lead for the Emerging Markets Regulatory Group @
2012 -2014 Director, International Regulatory Affairs, Oncology Therapeutic Area @
2005 -2012 Director, Global Regulatory Sciences, International @
2005 Associate Director, Regulatory Affairs @
James Sullivan Education
Temple University
Master Of Science (Pharmacy)
2000-2004
University Of Massachusetts - Dartmouth
Bachelor Of Science
1993-1997
James Sullivan Skills
Regulations
Cross Cultural Communication Skills
Clinical Trials
eCTD
Biotechnology
Regulatory Affairs
Life Sciences
Regulatory Requirements
Pharmacovigilance
Emerging Markets
Oncology
Drug Development
GCP
Cross Functional Team Leadership
Clinical Development
u.s. Food and Drug Administration Fda
Regulatory Submissions
Pharmaceutical Industry
Therapeutic Areas
Cross Cultural Teams
FDA
IND
Medical Affairs
u.s. Food and Drug Administration
James Sullivan Summary
James Sullivan, based in Boston, MA, US, is currently a Vice President Regulatory Affairs at Ardelyx, Inc.. James Sullivan brings experience from previous roles at Ultragenyx Pharmaceutical Inc., Ipsen, GE Healthcare and Takeda Pharmaceuticals. James Sullivan holds a 2000 - 2004 Master Of Science in Pharmacy @ Temple University. With a robust skill set that includes Regulations, Cross Cultural Communication Skills, Clinical Trials, eCTD, Biotechnology and more. James Sullivan has 2 emails and 1 mobile phone numbers on RocketReach.
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